Duns Number:099674145
Device Description: Disp, Bag Mask resus, LSP, Infant, Configuration
Catalog Number
DS203
Brand Name
Life Support Products
Version/Model Number
DS203
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K014071,K014071
Product Code
BTM
Product Code Name
Ventilator, Emergency, Manual (Resuscitator)
Public Device Record Key
97368d0c-7709-420c-86a8-714e076363b3
Public Version Date
May 05, 2020
Public Version Number
5
DI Record Publish Date
December 09, 2015
Package DI Number
40026072000241
Quantity per Package
16
Contains DI Package
00026072000243
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1099 |